The BioFire® Respiratory 2.1 (RP2.1) Panel (EUA)* detects SARS-CoV-2, along with 21 additional respiratory pathogens, to help clinicians quickly rule in and rule out common causes of respiratory illness in about 45 minutes.
*This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by authorized laboratories; this test has been authorized only for the detection and differentiation of nucleic acid of SARS-CoV-2 from multiple respiratory viral and bacterial organisms; and this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.